This is Steven Salzberg's blog on genomics, pseudoscience, medical breakthroughs, higher education, and other topics, including skepticism about unscientific medical practices. Here's where I can say what I really think about abuses and distortions of science, wherever I see them.

Another hero of the anti-vaccine movement bites the dust

I often wonder what motivates anti-vaccinationists. Are they in it because they truly believe they are offering valid treatments and advice? (Some of them do, I think.) Or are they just in it for baser reasons, such as money and fame?

Boyd Haley is a retired professor of chemistry from the University of Kentucky. His name has appeared several times in the Comments sections of this blog (for example, here and here), when commenters have presented him as a scientific expert supporting the claim that thimerosal in vaccines causes autism.

“I have been a strong proponent of investigating thimerosal as the casual agent for autism spectrum disorders based on the biological science that shows thimerosal to be incredibly toxic, especially to infants.”

Haley also wrote

“If, indeed, the complete removal of thimerosal from vaccines was not followed in an appropriate time by a decrease in autism then this would be solid proof that thimerosal was not causal for autism.”

Thimerosal was removed from childhood vaccines in the U.S. by 2002, and the rate of autism diagnoses continued to increase, but Haley simply changed his tune and continued to claim that thimerosal causes autism. The overwhelming (and still growing) evidence against the thimerosal-autism link has apparently done nothing to change his mind.

Is Haley simply a confused chemist who fails to understand epidemiological evidence? Or does he have another agenda?

Well, he does: money.

As Los Angeles Times reporter Trine Tsouderos wrote in a two-part story this past week, Haley and his company have been marketing a chelating agent – a powerful, highly toxic chemical that removes mercury from the bloodstream – as a treatment for autism. They also claim that this chemical, called OSR#1, is a harmless dietary supplement. Haley’s company, CTI Science, is selling OSR#1 as "a toxicity free, lipid soluble antioxidant dietary supplement." The LA Times ordered 30 100-milligram capsules of OSR#1 for $60 through an online pharmacy.

The FDA has sent Haley and his company a formal warning letter telling them to stop marketing this unapproved drug as a supplement. Haley’s claim that OSR#1 is a supplement is a flimsy attempt to try to avoid regulation of this dangerous chemical as a drug, though it clearly is a drug. (Dietary supplements are unregulated in the U.S. - a topic for another day.) The FDA letter is unambiguous, stating:

“this product is a new drug, as defined by section 201(p) of the Act, 21 U.S.C. § 321(p), because it is not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in its labeling.”

Just to be sure, I checked the CTI website today, and the main headline is “CTI Science Introduces OSR#1.” Haley is President and CEO of the company and his former University of Kentucky holds a patent on it. There are no clinical trials or other data showing that OSR#1 is safe or effective; on the contrary, the FDA letter explains that it has several serious side effects, including diarrhea, abnormalities of the pancreas, and lymphoid hyperplasia.

This hasn’t stopped Boyd Haley and his company from marketing their drug as a treatment for autism. The anti-vaccination site Age of Autism has promoted it; indeed, the LA Times reported that

[AoA’s] managing editor, Kim Stagliano wrote of sprinkling the white powder on her three daughters' breakfast sandwiches and orange juice. "We've seen some nice 'Wows!' from OSR," she wrote.

Boyd Haley may be misguided, but he has a deep financial reason for pushing the link between thimerosal and autism: without it, his company can’t sell its product.

Will the anti-vaccinationists start to doubt Dr. Haley? Will his obvious conflict of interest, and his violation of FDA regulations, make them wonder why he’s selling them a powerful, possibly harmful chelating agent to treat their children? I hope so.